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STOP-HAE: A Phase 3 Study of ADX-324 in HAE
EU CTIS ID: 2025-521352-38-00
What this study is testing
To evaluate the efficacy of ADX 324 in preventing HAE attacks.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Age ≥18 years.
- 2. Have a documented diagnosis of HAE-1or HAE-2 based upon ALL of the following (a, b, AND c): a) Documented clinical history consistent with HAE b) Diagnostic testing (historical documentation or during Screening, with option of one repeat test) that confirms 2 of the following: 1.C1-INH antigen level <50% the lower limit of normal (LLN). 2.C1-INH functional level <50% LLN. 3.C1-INH function ≥50% but ≤60% and a pathogenic mutation in the SERPING1 gene. 4.complement factor C4 level below the LLN. c) Have at least one of the following: 1.Age ≤30 years at reported HAE onset. 2.A family history consistent with HAE-1/HAE-2. 3.Complement component 1q within the normal range.
- 3. Must experience ≥1 Investigator-confirmed HAE attacks during the first 4-weeks of Screening or ≥2 Investigator-confirmed HAE attacks in 8 weeks of Screening.
- 4. Have access to, and the ability to use, acute HAE therapy to treat HAE attacks (e.g., plasma-derived or recombinant C1-INH concentrate or a BK2-receptor antagonist) that has been previously shown to be effective for the subject.
- 5. Subjects must be deemed medically appropriate for on-demand treatment as the sole medicinal management.
You likely can't join if
- 1. Concurrent diagnosis of another form of recurrent angioedema (acquired angioedema, HAE with normal C1-INH, idiopathic angioedema, and recurrent angioedema associated with urticaria).
- 2. History of alcohol or drug abuse within the previous year prior to Screening, or current evidence of substance dependence or abuse and/or self-reported alcoholic intake averaging >3 drinks/day.
- 3. Any clinically significant medical history including, but not limited to, uncontrolled HTN, uncontrolled DM, or current cardiovascular disease, including recent acute coronary syndrome (within the past 6 months), CHF (NYHA Class III or IV), significant arrhythmias, substance abuse, significant renal disease (CKD Stage 3 eGFR<60 ml/min/1.73 m²) h/o Nephrotic Syndrome), significant hepatic disease, h/o coagulopathies or bleeding diathesis, malignancy within 5 years, active infection (viral, bacterial, fungal, or parasitic) requiring systemic antimicrobial therapy, known HIV infection or positive serology test for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) during screening, Major surgery or significant traumatic injury within 30 days prior to signing the ICF.
- 4. Exposure to any of the following LTP for HAE: a. Chronic prophylaxis with C1-INH (CINRYZE, HAEGARDA, RUCONEST) within 2 weeks prior to Screening. b.Chronic prophylaxis with berotralstat (ORLADEYO) within 3 weeks prior to Screening. c. Chronic prophylaxis with lanadelumab (TAKHZYRO) within 8 weeks prior to the Screening. d. Androgen use within 12 weeks prior to Screening.
- 5. Exposure to any of the following medications: a. ACE inhibitors within 4 weeks prior to Screening. b. New use of or increase in dose of estrogen-containing medications with systemic absorption (such as oral contraceptives or hormonal replacement therapy) within3 months prior to Screening. Participants on a stable dose of estrogen-containing medications for ≥3 months prior to Screening are eligible.
- 6. Received prior treatment with any RNA/DNA-based therapy for HAE (including ADX-324) or is intolerant of any prior RNA/DNA-based therapy for any condition, excluding vaccines.
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong
- Argentina
- Israel
- Australia
- Turkey
- Canada
- Serbia
- United Kingdom
- United States
- Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong; Argentina; Israel; Australia; Turkey; Canada and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.